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Last Updated: April 17, 2025

CLINICAL TRIALS PROFILE FOR CEFAZOLIN AND DEXTROSE


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All Clinical Trials for Cefazolin And Dextrose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00108433 ↗ Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Terminated Pfizer Phase 3 2005-09-01 This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
NCT00130754 ↗ Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation Completed Hadassah Medical Organization Phase 3 2005-02-01 Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00323219 ↗ Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department Unknown status University of British Columbia Phase 3 2004-01-01 Patients often come to the emergency department with bacterial skin infections (known as "cellulitis"). Some patients with very severe infections are admitted to hospital for antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In this patient group it is unclear if treatment with oral antibiotics is as effective as intravenous antibiotics. The purpose of this study is to determine if treatment of moderate cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be as effective as intravenous treatment for moderate cellulitis.
NCT00330278 ↗ Timing of Prophylactic Antibiotics for Cesarean Sections Completed Medical University of South Carolina N/A 2003-01-01 This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.
NCT00467948 ↗ Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients Completed Tehran University of Medical Sciences Phase 3 2004-06-01 Patients who need major head & neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen
NCT00550290 ↗ Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy Completed Aultman Health Foundation Phase 4 2007-10-01 This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefazolin And Dextrose

Condition Name

Condition Name for Cefazolin And Dextrose
Intervention Trials
Surgical Site Infection 12
Infection 7
Obesity 7
Wound Infection 6
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Condition MeSH

Condition MeSH for Cefazolin And Dextrose
Intervention Trials
Infections 38
Infection 29
Surgical Wound Infection 23
Communicable Diseases 22
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Clinical Trial Locations for Cefazolin And Dextrose

Trials by Country

Trials by Country for Cefazolin And Dextrose
Location Trials
United States 130
Canada 23
Australia 10
Brazil 10
Israel 7
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Trials by US State

Trials by US State for Cefazolin And Dextrose
Location Trials
California 9
Texas 9
New York 9
Pennsylvania 8
Missouri 7
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Clinical Trial Progress for Cefazolin And Dextrose

Clinical Trial Phase

Clinical Trial Phase for Cefazolin And Dextrose
Clinical Trial Phase Trials
Phase 4 57
Phase 3 23
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Cefazolin And Dextrose
Clinical Trial Phase Trials
Completed 68
Recruiting 26
Unknown status 22
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Clinical Trial Sponsors for Cefazolin And Dextrose

Sponsor Name

Sponsor Name for Cefazolin And Dextrose
Sponsor Trials
Population Health Research Institute 4
B. Braun Medical Inc. 4
Duke University 3
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Sponsor Type

Sponsor Type for Cefazolin And Dextrose
Sponsor Trials
Other 218
Industry 20
NIH 7
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Cefazolin and Dextrose: Clinical Trials Update, Market Analysis, and Projections

Introduction

Cefazolin, a semi-synthetic, first-generation cephalosporin antibacterial drug, has been a cornerstone in the treatment of various bacterial infections. When combined with dextrose, it is administered intravenously, particularly for perioperative prophylaxis and the treatment of several infections. Here, we delve into the recent clinical trials updates, market analysis, and projections for Cefazolin and Dextrose.

Clinical Trials Update

New Dosing Regimen for Perioperative Prophylaxis

A recent efficacy supplement submitted to the FDA proposes a new dosing regimen of 3 g/150 mL of Cefazolin in Dextrose Injection for perioperative prophylaxis in adult patients weighing ≥ 120 kg. This application, filed by Baxter HealthCare Corporation, includes pharmacokinetic (PK) studies comparing the PK exposure between subjects weighing less than 120 kg receiving 2 g/100 mL and those weighing ≥ 120 kg receiving the new 3 g/150 mL dose[1].

Pharmacokinetic Study Findings

The PK study revealed that plasma concentrations of cefazolin exhibited low intrasubject variability, with geometric mean ratios (GMR) for Cmax and AUC0-t indicating bioequivalence between the two dosing groups. However, the upper bound of the 90% confidence interval for the AUC ratio slightly exceeded the acceptance criteria of 125%, suggesting a need for further evaluation[1].

Safety and Efficacy

The clinical trials experience and pediatric use sections of the drug label have been updated to include details on clinical trial data, adverse reactions, and safety and efficacy in pediatric patients. The most frequently reported adverse reactions include nausea, infusion site pain, and headache[3][4].

Market Analysis

Market Size and Forecast

The cefazolin injection market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031. This growth is driven by increasing demand in hospitals, clinics, and recovery centers. The market is segmented by application, product (1g/50ml, 2g/100ml), and geography (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Key Market Drivers

  • Increasing Infections: The rise in bacterial infections, particularly in surgical settings, has boosted the demand for effective antibacterial drugs like cefazolin.
  • Expanding Healthcare Infrastructure: Growing healthcare infrastructure in emerging markets is contributing to the increased use of cefazolin injections.
  • Product Diversification: The introduction of new dosing regimens, such as the proposed 3 g/150 mL dose, is expected to expand the market reach[2].

Market Restraints

  • Antibiotic Resistance: The increasing concern over antibiotic resistance could impact the long-term demand for cefazolin.
  • Regulatory Challenges: Stringent regulatory requirements and the need for continuous clinical trials can pose challenges to market growth[2].

Market Projections

Revenue Growth

The cefazolin injection market is projected to experience significant revenue growth, driven by sustained expansion in the healthcare sector. The market size is expected to increase substantially from its current valuation, with forecasts indicating a robust growth rate over the next several years[2].

Geographical Trends

North America and Europe are expected to remain major markets due to their well-established healthcare systems. However, the Asia-Pacific region is anticipated to show the highest growth rate due to rapid healthcare infrastructure development and increasing demand for antibacterial treatments[2].

Key Players

Major players in the cefazolin injection market include B Braun, Baxter, Hikma, Pfizer, Sagent, and others. These companies are focusing on product diversification, strategic partnerships, and expanding their geographical presence to capture a larger market share[2].

Indications and Usage

Respiratory Tract Infections

Cefazolin in Dextrose Injection is indicated for the treatment of respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus, and Streptococcus pyogenes in adults and pediatric patients[3].

Urinary Tract Infections

It is also effective in treating urinary tract infections due to Escherichia coli and Proteus mirabilis[3].

Skin and Skin Structure Infections

The drug is indicated for skin and skin structure infections caused by S. aureus, S. pyogenes, and Streptococcus agalactiae[3].

Other Indications

Cefazolin in Dextrose Injection is used for biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis, among other conditions[3].

Key Takeaways

  • New Dosing Regimen: A new 3 g/150 mL dosing regimen for perioperative prophylaxis in adult patients weighing ≥ 120 kg has been proposed.
  • Market Growth: The cefazolin injection market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031.
  • Geographical Expansion: The Asia-Pacific region is anticipated to show the highest growth rate due to rapid healthcare infrastructure development.
  • Key Players: Major pharmaceutical companies are focusing on product diversification and strategic partnerships to capture a larger market share.
  • Indications: Cefazolin in Dextrose Injection is indicated for a wide range of bacterial infections.

FAQs

What is the new proposed dosing regimen for Cefazolin in Dextrose Injection?

The new proposed dosing regimen is 3 g/150 mL for perioperative prophylaxis in adult patients weighing ≥ 120 kg[1].

What are the key drivers of the cefazolin injection market?

The key drivers include increasing demand in hospitals and clinics, expanding healthcare infrastructure, and product diversification[2].

Which regions are expected to show significant growth in the cefazolin injection market?

North America and Europe are major markets, but the Asia-Pacific region is anticipated to show the highest growth rate due to rapid healthcare infrastructure development[2].

What are the common adverse reactions associated with Cefazolin in Dextrose Injection?

Common adverse reactions include nausea, infusion site pain, and headache[3][4].

What are the indications for Cefazolin in Dextrose Injection?

Cefazolin in Dextrose Injection is indicated for respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis[3].

Sources

  1. FDA Office of Clinical Pharmacology Review: "Cefazolin in Dextrose Injection" - FDA.
  2. Market Research Intellect: "Cefazolin Injection Market Size And Forecast".
  3. Baxter PI: "Cefazolin in Dextrose Injection" - Baxter PI.
  4. Coram: "Drug Labeling Updates – February 2024" - Coram.

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